Interventional Ultrasound Probe

ABSTRACT

A method and system are provided for guiding a needle to a target location within a subject. The system comprises a probe and a needle guide. The probe includes two or more transducers that are arranged to direct sound waves toward a target location on a subject. The needle guide can be detachably coupled to the probe, and may be used to maintain the needle within viewing planes of the transducers while the needle is inserted into the subject. To facilitate guidance of the needle, a real-time image of the target region can be produced by overlaying images produced by the two or more transducers. Such a system may provide a more adaptive and reliable way to guide the insertion of a needle, allowing for more sophisticated and fool-proof viewing planes, improved versatility, and more ergonomic needle control.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority to U.S. ProvisionalApplication No. 62/482,387 entitled “INTERVENTIONAL ULTRASOUND PROBE ANDMETHODS OF MAKING AND USING SAME,” filed on Apr. 6, 2017, the contentsof which are hereby incorporated by reference in their entirety.

BACKGROUND

Unless otherwise indicated herein, the materials described in thissection are not prior art to the claims in this application and are notadmitted to be prior art by inclusion in this section.

Insertion of needles into blood vessels is a common intervention forinsertion of venous catheters, arterial catheters, and blood sampling.Similarly, insertion of biopsy needles into tumors and other tissues canprovide diagnostic information to guide treatment. Use of real-timeultrasound can greatly improve accuracy of these tasks by allowingvisualization of the needle entering the target structure. Additionally,the use of ultrasound guidance can reduce complications and improvespeed by allowing visualization of the non-target organs and structuressurrounding the target structure. Given these benefits, ultrasound isroutinely utilized for insertion of venous catheters and biopsy oflesions in solid organs. Despite its widespread use, ultrasound guidanceis frequently performed suboptimally, because optimal use of ultrasoundfor needle guidance is a challenging skill that benefits fromspecialized training and substantial experience to establishproficiency. Specifically, maintaining the needle within the viewingplane of the ultrasound beam is important for proper visualization ofthe needle path. However, such a task is highly challenging.

Needle guides exist for the purpose of maintaining the needle along aviewing plane of the ultrasound. Such needle guides may include clip-onattachments for ultrasound transducers that help guide the angle andtrajectory of a needle. However, due to conventional needle guides beingpositioned at a peripheral aspect of the ultrasound transducer, theneedle angle increases the distance to be traversed to the targetregion. Furthermore, existing guide systems provide that the needletraverse various tissue layers at an angle, which can skew the needlepath. This skewing can potentially cause the needle to leave the viewingplane of a given transducer and render the ultrasound guidance techniqueineffective.

SUMMARY

The present disclosure generally relates to a system and method for aninterventional ultrasound probe that provides guidance for a needleinserted into a subject. Such a system may include two or moretransducers and a needle guide that positions a needle within theviewing planes of the transducers, allowing the needle to be visualizedin real-time by a user.

In a first aspect, a system is provided. The system includes a probe anda needle guide detachably coupled to the probe. The probe comprises afirst transducer and a second transducer. The first transducer andsecond transducer are arranged such that sound waves provided by thefirst and second transducers are emitted toward a target location of asubject. The needle guide is disposed between the first transducer andthe second transducer such that a needle inserted through the needleguide is configured to extend toward the target location.

In a second implementation, a method is provided. The method includespositioning a first transducer and a second transducer proximate to atarget location of a subject. The needle guide is disposed between thefirst transducer and the second transducer such that a needle insertedthrough the needle guide is configured to extend toward the targetlocation. The method further includes causing the first transducer andthe second transducer to emit sound waves such that at least a portionof the sound waves are emitted toward the target location. Additionally,the method includes receiving, at the first and second transducers,information indicative of reflected sound waves and generating areal-time image of the target location based on the receivedinformation. Yet further, the method includes inserting a needle throughthe needle guide so as to intersect with the target location.

Other aspects, embodiments, and implementations will become apparent byreading the following detailed description with reference, whereappropriate, to the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A illustrates a side view of a probe, according to an exampleembodiment.

FIG. 1B illustrates a side view of an endocavitary probe, according toan example embodiment.

FIG. 2A illustrates a cross sectional side view of a probe that includeslinear transducers, according to an example embodiment.

FIG. 2B illustrates a schematic of a transducer arrangement, accordingto an example embodiment.

FIG. 3 illustrates a perspective view of a probe, according to anexample embodiment

FIG. 4 illustrates a perspective view of a probe, according to anexample embodiment

FIG. 5 is a flowchart illustrating a method, according to an exampleembodiment.

FIG. 6A shows ultrasound images of a target location generated accordingto an example embodiment.

FIG. 6B shows the ultrasound images of FIG. 6A overlaid to provide areal-time image of an image region, according to an example embodiment.

DETAILED DESCRIPTION

Example methods, devices, and systems are presently disclosed. It shouldbe understood that the word “example” is used in the present disclosureto mean “serving as an instance or illustration.” Any implementation orfeature presently disclosed as being an “example” is not necessarily tobe construed as preferred or advantageous over other implementations orfeatures. Other implementations can be utilized, and other changes canbe made, without departing from the scope of the subject matterpresented in the present disclosure.

Thus, the example implementations presently disclosed are not meant tobe limiting. Components presently disclosed and illustrated in thefigures can be arranged, substituted, combined, separated, and designedin a wide variety of different configurations without departing from thescope of this disclosure.

Unless context suggests otherwise, the features illustrated in each ofthe figures can be used in combination with one another. Thus, thefigures should be generally viewed as components of one or more overallimplementations, with the understanding that not all illustratedfeatures are necessary for each implementation.

In an effort to provide technical context for the present disclosure,the information in this section can broadly describe various componentsof the implementations presently disclosed. However, such information isprovided solely for the benefit of the reader and, as such, does notexpressly limit the claimed subject matter. Further, components shown inthe figures are shown for illustrative purposes only. As such, theillustrations are not to be construed as limiting. As is understood,components can be added, removed, or rearranged without departing fromthe scope of this disclosure.

Further, while embodiments disclosed herein may make reference to use onor in conjunction with a living human body, it is contemplated that thedisclosed methods, systems, and devices may be used in any environmentwhere guided needle insertion is desirable. The term “subject” may referto any living or non-living body or a portion thereof. In someembodiments, the subject is a human patient.

Additionally, the term “target location” as used herein should beunderstood broadly to include any internal or external region, feature,tissue, organ, lesion, vessel, area of skin, cavity, tumor, lumen, orany other desired target for a guided needle.

I. Overview

For particular applications, it could be beneficial to provide a systemand method for guiding a needle to a target location on a subject. Forinstance, a medical professional may desire to guide a needle into ablood vessel for insertion of venous catheters, arterial catheters, orblood sampling. Likewise, guidance of needles into other tissues may beimportant for biopsies, diagnostic testing, amniocentesis, thermalablation, fluid drainage, and other procedures. In such cases, it can beadvantageous to use a needle guidance system that provides real-timeultrasound imaging of the target location. By generating a real-timeimage of a target location using two or more ultrasound transducers, auser may be able to visualize a needle throughout its entire path fromskin to target. A needle guidance system may also desirably include awide ultrasound viewing plane (i.e. sonographic plane). For manyprocedures, it could also be advantageous to constrain the path of theneedle along the center of the sonographic plane of the transducersusing e.g., a needle guide, in order to reduce error. Furthermore,perpendicular insertion of the needle may also be desirable, limitingthe needle's parenchymal path to reach a target location.

Systems, devices, and methods herein generally relate to controllablyguiding a needle to a target location. Specifically, needle guidance maybe carried out using a system including a probe (e.g., an interventionalultrasound probe) and a needle guide.

The probe may include a plurality of transducers operable to visualize aneedle in real-time using ultrasound or another imaging technique.Providing two or more transducers arranged proximate to the interventionsite may improve visualization of the target location and/or needle,broaden the viewing plane, and reduce the risk of “losing” the needle ina “blind spot” at an edge of the transducer's viewing plane. Images fromthe plurality of transducers can be geometrically overlaid to enhancethe user's view of the target region and/or the needle and reduce thechance of error in interventional procedures.

In an example, the probe may include a first transducer and a secondtransducer arranged such that sound waves provided by the first andsecond transducers are emitted toward a target location of a subject.The transducers could be arranged in the same plane relative to thetarget location and angled toward each other such that their respectivesound waves converge at the target location. In some embodiments, thenumber, type, size, and arrangement of the transducers may varydepending on the environment of use, the nature of the medicalintervention, and the target tissue. For instance, in some examples, aprobe could include three, four, five, six, or more transducers arrangedto image the target location. Similarly, the transducers could bearranged such that sound waves are directed to propagate throughopposite sides of the target location (i.e., to approximate a “front”and “back” view), in parallel directions, in perpendicular directions,or from a range of different angles surrounding the target location.

Likewise, the probe may come in a range of shapes and sizes. Forinstance, a probe configured for external use (e.g., on a subject'sskin) could include a diameter in a range of about 2 cm to 10 cm.Alternatively, a smaller form factor may be desired for internal use,with a diameter ranging from about 5 mm to 20 mm for internalapplications. In yet a further example, the probe may be sized forendovascular use within arteries or veins, and may have a still smallerform factor (e.g., 5 mm diameter or less).

The system may also include a needle guide detachably coupled to theprobe between the two transducers, such that a needle inserted throughthe needle guide is configured to extend toward the target location. Forexample, the needle guide could be disposed in between two or more ofthe transducers, in a space within a housing of the probe, or in anotherlocation that facilitates needle entry through the guide and into thesubject along the ultrasound imaging plane. The needle guide could beconfigured to constrain a needle along a specified path in the directionof the target location (e.g., a path along a center of a sonographicplane of the transducers). In some examples, the needle guide may bedisposable and provided separately from the probe. In such cases, theneedle guide may include a coupler (e.g., a shaft coupling, a magneticcoupling, a clip coupling, a mating coupling, or another couplingmechanism) so that the needle guide can be secured to the probe prior toand during needle guidance and can be removed and replaced after use.

Further, such a system could include a controller communicativelycoupled to the transducers. The controller may be configured to actuatethe transducers to emit sound waves, receive information at thetransducers indicative of reflected sound waves, and/or generate areal-time image of the target location to guide insertion of the needle.A real-time image of the target location may be created by generating afirst and second image of the target location based on informationreceived from the first and second transducers, respectively, andsuperimposing (i.e., overlaying) or merging the respective images toprovide a real-time 3-dimensional composite image. The controller couldfurther be communicatively coupled to a display (e.g., an ultrasoundmonitor). Images produced by each transducer could be viewed as separatereal-time images on the display. In some embodiments, the controller mayalso allow a user to affect operation of the transducers, e.g., bychanging an ultrasound emission frequency (or frequency band) oradjusting a direction of propagation of the emitted sound waves.

II. Example System

FIG. 1A illustrates a side view of a system 100 according to an exampleembodiment of the present disclosure. As shown in FIG. 1A, one aspect ofsystem 100 includes a probe 160 and a needle guide 150 detachablycoupled to the probe 160. The probe 160 includes a first transducer 120and a second transducer 122. Sound waves 170 provided by the firsttransducer 120 propagate along a first propagation direction 175, andsound waves 172 provided by the second transducer propagate along asecond propagation direction 177. The first transducer 120 and thesecond transducer 122 may be arranged such that the sound waves 170 and172 provided by the first transducer 120 and second transducer 122 areemitted toward a target location 180 on a subject. That is, the firsttransducer 120 and the second transducer 122 may be arranged at an anglewith respect to each other such that the sound waves 170 and 172transmitted therefrom create overlapping viewing planes (i.e., an imageregions that are visible by the first transducer 120 and/or secondtransducer 172) over the target location 180.

The system 100 of the present disclosure may be configured to guide theneedle 140 to a range of structures, for instance, a tissue, vessel,tumor, organ, lesion, area of skin, lumen, or body cavity. In somecases, the system 100 could be configured for external use, and theprobe 160 could be configured to be positioned over a skin area of thesubject. Additionally or alternatively, in some embodiments the system100 could be configured for internal use (e.g., use within a bodycavity, for instance, the gastrointestinal tract, bronchial tree,rectum, vagina, urethra, ureter, biliary tree, peritoneal cavity, orpleural cavity). FIG. 1B illustrates such an embodiment, where the firsttransducer 120 and the second transducer 122 are arranged within a probe160 configured for internal use. In some embodiments, probe 160 could betermed an endoscopic probe, an endocavity probe, or an endocavitaryprobe without limitation. Such a probe 160 could include a smaller formfactor, with a diameter ranging from about 5 mm to 20 mm. Forendovascular use (i.e., within arteries or veins), the probe 160 couldinclude a still smaller form factor, for example, 5 mm diameter or less.In some examples, the probe 160 could include a shaft 165 that isarticulated such that the probe can bend and conform to its environment(e.g., the shape of a tract, body cavity, or vasculature). In someembodiments, a directionality and/or articulation of the probe 160 couldbe controllable by e.g., a controller in communication with the probe160. Controllable articulation and/or directionality may facilitateoperation of the probe 160 by allowing more precise navigation of bodycavities and/or multidirectional imaging and needle insertion.

Returning to FIG. 1A, the first transducer 120 and the second transducer122 may be configured to emit sound waves 170 and 172 toward a targetlocation 180 and receive information indicative of reflected sound wavesfrom the target location 180. The transducers 120, 122 may provide soundwaves 170 and 172 at a range of different and/or adjustable frequenciesor frequency ranges. For instance, sound waves 170 and 172 provided bythe first transducer 120 and the second transducer 122 may varydepending on a depth of the target location 180 (i.e., a distance from askin surface or another lumen of the subject), a distance of the targetlocation 180 from the probe 160, a size or shape of the target locationor feature, a tissue density or characteristic, or another variable. Insome example embodiments, the sound waves 170 and 172 provided by thefirst transducer 120 and the second transducer 122 could include one ormore frequencies within a frequency range of about 1 MHz to 22 MHz.Additionally or alternatively, the first transducer 120 and/or thesecond transducer 122 could include a transducer that operates at loweror higher frequencies. As an example, the emitted sound waves 170 and172 could include frequencies within a range of about 2 MHz to 7.5 MHz.Many other frequencies or ranges of frequencies may be possible withinthe scope of the present disclosure. Yet further, in some embodiments,the first transducer 120 and/or the second transducer 122 could includeone or more phased array transducers, which could be configured tocontrollably steer the ultrasonic waves in a desired direction.

In some embodiments described herein, a needle could be guided to atarget location based on ultrasound images obtained from informationprovided by transducers 120, 122. However, the probe 160 mayadditionally or alternatively be used for photoacoustic imaging, wheredetection is done by measuring absorption of electromagnetic waves andlocalized thermal excitation. Other interventional imaging modalitiesare contemplated.

As used herein, the terms “transducer” and “transducer element” are usedinterchangeably and refer to the component of the probe 160 that isconfigured to produce a signal (e.g., sound waves 170 and 172) andreceive a further signal (e.g., reflected sound waves) from the targetlocation 180. Transducers 120, 122 may come in a range of shapes, sizes,and configurations as desired for a specific application or treatmentarea. In some embodiments, a single ultrasound transducer may contain aplurality of elements (e.g., piezoresistive crystals) operable toproduce ultrasonic waves. The number or configuration of elements of thetransducers 120, 122 may determine the size, shape, and/or resolution ofthe viewing plane (i.e., image region) of the transducers. For instance,the elements of transducers 120, 122 may be arranged in a rectangulararray, in a linear row, in a circular shape, or in any other desiredfootprint or shape.

Additionally, elements of the first transducer 120 and the secondtransducer 122 can be arranged to give the transducers a variety of beamshapes, i.e., the direction of propagation 175, 177 of sound waves 170and 172 produced by the transducers 120, 122. For instance, at least oneof the first transducer 120 and/or the second transducer 122 may includeelements arranged in a convex shape, such that sound waves 170 and 172emitted from the transducer propagate radially outward from the givensource transducer. Alternatively, at least one of the first transducer120 and/or the second transducer 122 may include elements arranged in aplanar shape (i.e., such that sound waves 170 and 172 propagate along asubstantially planar or linear beam path), or a concave shape (i.e.,such that sound waves 170 and 172 propagate radially inward toward atarget location 180).

In some embodiments, the first transducer 120 and the second transducer122 could be communicatively coupled (e.g., via a wired or wirelesscommunication interface) to a controller 190. The controller 190 couldinclude, as an example, a computing device configured to control some orall of the operations of the first transducer 120 and the secondtransducer 122. In example embodiments, the controller 190 could provideelectrical signals to the transducers that are transduced or otherwiseconverted into sound waves (e.g., sound waves 170 and 172). Furthermore,controller 190 could be configured to receive information from thetransducers indicative of interactions between the sound waves and aparticular environment or location (e.g., a patient's body). Thecontroller 190 could also be configured to form respective ultrasoundimages based on the received information. The controller 190 couldadditionally be configured to perform image processing operations (e.g.,image merging, image addition, image subtraction, etc.) with therespective ultrasound images so as to provide a merged ultrasound image.In some embodiments, the controller 190 could be similar or identical tocontrollers 290 and 390 as illustrated and described in reference toFIGS. 2A and 3, respectively.

The first and/or second transducers 120, 122 described herein couldinclude any transducer configurations currently known and/orcommercially available, such as linear array transducers, convextransducers, phased array transducers, endocavity transducers, penciltransducers, or other types. As illustrated in FIG. 2A, at least one ofthe first transducer 220 or the second transducer 222 could include alinear array transducer. In such embodiments, transducers 220, 222 couldinclude an array of elements arranged in a generally rectangular orlinear arrangement. Adjacent elements may be oriented in substantiallythe same direction, such that sound waves 270 and 272 emitted from thetransducers 220, 222 propagate with a linear beam shape (i.e., alongrespective parallel paths in the same direction toward the targetlocation 180). However, any transducer type, element configuration,and/or beam shape may be used without departing from the presentdisclosure.

The region traversed by the sound waves 270 and 272 emitted from firsttransducer 220 and the second transducer 222 and reflected from thetarget location 280 may approximate a viewing plane of the transducers220, 222. As illustrated in FIG. 2B, sound waves 270 provided by thefirst transducer 220 may propagate along a first propagation direction275, while sound waves 272 provided by the second transducer 222propagate along a second propagation direction 277. The arrangement ofthe transducers 220, 222 can be selected to optimize the propagationpaths of the two transducers, enhance needle visualization, adjust thevisible region, improve image resolution, optimize the size or shape ofthe probe 260, improve placement of needle guide 250, or provide someother benefit. The first transducer 220 and the second transducer 222may be arranged such that a plane of the first transducer 202 is at arelative angle 206 relative to a plane of the second transducer 204. Therelative angle 206 between the transducers 220, 222 could be selected inorder to adjust the imaging depth of the probe 260 (i.e., to visualize aneedle 240 and/or target area 280 that is farther from the probe 260).In some embodiments, the relative angle 206 could be selected fromvalues within a range of about 90 degrees to 170 degrees. In otherembodiments, the relative angle 206 may be adjustable, such that soundwaves 270 and 272 provided by the first transducer 220 and the secondtransducer 222 are controllably emitted toward a selectable targetlocation 280.

As illustrated in FIG. 2A, the transducers 220, 222 may be positioned onopposite sides of the needle guide 250. In such a configuration, soundwaves 270 and 272 emitted from the first transducer 220 and the secondtransducer 222 are directed toward opposite sides of a needle when aneedle is inserted through the needle guide 250 and extended toward thetarget location 280, thereby providing a “front” and “back” view of thetarget location 280. However, the first transducer 220 and the secondtransducer 222 may be arranged such that the sound waves 270 and 272emitted therefrom intersect at a variety of angles relative to thetarget location 280. In another example, the first transducer 220 andthe second transducer 222 are arranged to provide a “front” and “side”view, respectively, when the needle is extended into the target location280. In such an example, the first transducer 220 may be offsetapproximately 90 degrees from the second transducer 222 relative to theneedle guide 250 and/or target location 280. In this configuration,sound waves 270 and 272 emitted from the first transducer 220 and thesecond transducer 222 may converge at the target location 280, where thefirst propagation direction 275 and the second propagation direction 277are substantially perpendicular.

In some examples, the propagation direction of the first transducer 220and/or the second transducer 222 could be adjustable (i.e., by adjustinga plane of the first transducer 202 or a plane of the second transducer204) so as to allow a user of the probe 260 to adjust a field of viewand/or a depth of field of the area that is imaged. For instance, itcould be desirable to change an angle of one or more of the transducers220, 222 relative to the target location 180 to visualize a feature thatis farther away from the probe 260, or to follow a needle as it isinserted further into the subject. In such an example, the firstpropagation direction 275 and the second propagation direction 277 maybe selected (e.g., through a controller 290 or a user interface of theprobe 260), such that sound waves 270 and 272 provided by the firsttransducer 220 and the second transducer 222 are controllably emittedtoward a selectable or desired target location 280.

The first transducer 220 and second transducer 222 may be secured withinthe probe 260 in any suitable manner that maintains the transducers 220,222 in their correct position, such as fasteners, epoxies, glues and thelike. Additionally or alternatively, the transducers 220, 222 may besecured within the probe 260 by way of a housing 210, a scaffolding,etc. Such a housing 210 may be configured to surround the firsttransducer 220 and the second transducer 222 and/or provide mechanicalsupport for the needle guide 250. In some embodiments, the firsttransducer 220 and/or the second transducer 222 are removable from thehousing 210 such that the transducers 220, 222 can be rearranged,replaced, and/or repaired. However, in other examples, the transducers220, 222 could be permanently affixed to the housing 210 and/orscaffolding of the probe 260.

In some cases, the housing 210 of the probe 260 includes a spacepositioned between the first transducer 220 and second transducer 222(i.e., a space shaped to receive a needle guide 250). The space may beof such a size and configuration so as to accommodate a disposableneedle guide 250 such that a needle inserted through the needle guide250 will pass through the overlapping viewing planes generated by thetransducers 220, 222 and intersect the target location 280. The spacemay be located such that a needle inserted through the needle guide 250is configured to extend toward the subject in a direction substantiallyperpendicular to a skin surface or other surface of the subject. In someembodiments, the space in the housing 210 may also include a coupler(e.g., a shaft coupling, a magnetic coupling, a clip coupling, or amating coupling) or some other attachment mechanism configured to securethe needle guide 240 to the probe 260.

The system 200 may further include a needle guide 250 for directing thepath of a needle into the target location 280 (e.g., into a portion of asubject that is within the viewing plane of the transducers 220, 222).As shown in FIG. 2A, the needle guide 250 may be disposed between thefirst transducer 220 and second transducer 222 such that a needleinserted through the needle guide 250 is configured to extend toward thetarget location 280. In order to be visualized by the transducers 220,222, the path of the needle must intersect the sound waves 270 and 272such that the sound waves may be reflected from the needle and returnedto the transducers 220, 222. Accordingly, the needle guide 250 may bedisposed such that a path of the needle is angled to intersect thedirection of propagation 275, 277 of at least one of the firsttransducer 220 and/or the second transducer 222 (i.e., such that theneedle does not run parallel to the direction of propagation of thesound waves 270 and 272). In other words, in some embodiments the needleguide 250 constrains the needle in a specified path 255, which mayextend toward the target location 280 through the viewing planes of thetransducers. As described herein, the specified path 255 may besubstantially perpendicular to a skin surface or other surface of thesubject. In other embodiments, the specified path 255 may be orientedsuch that a needle is inserted at a specified angle relative to theskin, relative to the probe 260, or in some other specified path. Yetfurther, in some examples the needle and/or needle guide 250 may bemanipulable such that a user of the probe 260 may manipulate the needleas necessary to reach the target location 280.

In some examples, the needle guide 250 may be supplied separately fromthe probe 260 so that it may be provided in a sterile state and disposedof after use (e.g., after a single use, after use on a single patient orby a single practitioner, or after another pattern of use). In such acase, the needle guide 250 may be detachably coupled to the probe 260,such that a user may secure the needle guide 250 prior to and duringinsertion of the needle, and then remove and replace the needle guide250 after use. The needle guide 250 may be formed of any number ofsuitable materials, such as plastics and/or polymers; however, othermaterials such as metal, ceramics, and/or composite materials may beused.

In some examples, the needle guide 250 includes a coupler configured tosecure the needle guide to the probe 260. The coupler could beconfigured to detachably couple the needle guide 250 to the probe 260,to a housing 210 of the probe 260, to a space in the probe 260 and/orhousing 210, or at some other element of the system 200. In variousembodiments, the coupler could include a shaft coupling, a magneticcoupling, a clip coupling, or a mating coupling; however, other types ofcouplings are contemplated.

To facilitate operation of the probe 260, the system 200 may furtherinclude a controller 290 communicatively coupled to the first transducer220 and the second transducer 222. As defined herein, the term“communicatively coupled” includes both hardwiring, such as by a cable,or wireless communication. In some examples, the controller 290communicates with the first transducer 220 and the second transducer 222via a wireless communication protocol. Wireless communication protocolsinclude, but are not limited to, BLUETOOTH®, Wi-Fi, IRdA®, ZIGBEE®,WiMAX®, wireless infra-red, and wireless USB. The controller 290 mayalso communicate with the transducers 220, 222 over a wireless network,which could include, but need not be limited to, mobile body areanetworks (MBAN), CDPD, CDMA, GSM, PDC, PHS, TDMA, FLEX, ReFLEX, iDEN,TETRA, DECT, DataTAC, Mobitex, EDGE, 2G, 3G, 4G. and LTE.

While some examples and figures herein describe devices or systems thatinclude some elements (e.g., transducers) as being physically coupled ina wired fashion to other elements of the system (e.g., a controller), itwill be understood that embodiments including wireless communicationbetween at least two device or system elements are also contemplated. Asan example, some embodiments could include a transducer and needle guideportion that is wirelessly coupled to a corresponding controller. Suchwireless coupling could provide several benefits. For example, a medicalprofession might be able to more easily manipulate the sensor or probeportion without the wired connection. Additionally or alternatively, aprobe diameter of a probe (e.g., an endoscopic probe, an endocavityprobe, or an endocavitary probe) could be smaller due to no need for aphysical wire connection between the transducers and their correspondingcontroller.

In some examples, the controller 290 is an image processing unit of anultrasound system, and includes additional software to allow for imageoverlay/merging and multi-plane viewing. The controller 290 may includea processor and a memory and be operable to execute operations of thesystem 100. For example, the controller 290 may be operable to actuatethe first transducer 220 and/or second transducer 222 to emit soundwaves 270 and 272 toward a target location 280 and receive informationindicative of reflected sound waves from the location. In some examples,the controller 290 is configured to store the data (i.e., the receivedinformation) and/or transmit the data to corresponding computingdevices, such as an associated computer, a mobile device, or a cloudnetwork server.

The controller 290 may also be configured to aid in the processing ofinformation (i.e., raw data) received from the first transducer 220 andsecond transducer 222. For example, the controller 290 could be operableto generate a real-time 3-dimensional image of the target location 280based on the received information to visualize the insertion of a needleand/or guide the needle to the target location 280. More specifically,the controller 290 could be operable to generate a first image of thetarget location 280 based on information received by the firsttransducer 220. The controller 290 could additionally be operable togenerate a second image of the target location 280 based on informationreceived by the second transducer 222. The controller 290 may also beoperable to overlay the first image and the second image to provide areal-time and/or 3-dimensional image of the needle and/or targetlocation 280. In some embodiments, the controller 290, the firsttransducer 220, and/or the second transducer 222 could becommunicatively coupled to a display (e.g., an ultrasound monitor). Insuch an embodiment, the controller 290 could be operable to display thefirst image, the second image, and/or the real-time 3-dimensionalrendering of the target location based on the first and second images.

The controller 290 could also be configured to adjust various aspects ofthe operation of the transducers 220, 222. For example, the controllercould be configured to adjust a frequency of sound waves 270 and 272emitted by at least one of the first transducer 220 or the secondtransducer 222. The controller may also be configured to adjust adirection of propagation of sound waves 270 and 272 emitted from thetransducers 220, 222, i.e., to adjust a viewing plane (i.e., imageregion) of the system. Additional or alternative functions of thecontroller 290 are contemplated herein.

While systems 100, 200 have insofar been described as including a firstand second transducer, an interventional ultrasound probe according tothe present disclosure may comprise other configurations. As illustratedin FIGS. 3-4, in some embodiments the probe 360 may include a thirdtransducer 324 or even further transducers to aid in visualization ofthe needle and/or the target location. In some embodiments, a thirdtransducer 324 may be arranged such that sound waves 370 provided by thethird transducer 324 are emitted toward the target location 380 (i.e.such that a viewing plane of the third transducer 324 converges with thetarget location). The third transducer 324 or a further transducer mayalso be communicatively coupled to a controller 390 such thatinformation received from the transducer can be processed and/or usedfor generation of a real-time image. In such embodiments, the controller390 could be communicatively coupled to a display, and real-time imagesgenerated from each transducer could be displayed separately.Additionally or alternatively, images from some or all of thetransducers could be merged to provide a real-time 3-dimensional image,using e.g., an image processing software to render the image.

A first transducer 320, a second transducer 322, and third transducer324 of a probe 360 may be arranged in a number of configurationsrelative to a target location 380 to be imaged. FIG. 3 illustrates onesuch configuration, including a first transducer 320, a secondtransducer 322, and a third transducer 324 coupled according to anarrangement. In some examples, the arrangement could include a concaveshape, such that sound waves 370 propagated from the transducers 320,322, 324 converge on the same target location 380. As shown in FIG. 3,at least one of the first transducer 320, the second transducer 322,and/or the third transducer 324 could include one or more linear arraytransducers. In some examples, a plurality of linear array transducersmay be arranged in parallel planes such that sound waves 370 emittedfrom the plurality of transducers form a plurality of viewing planesthat converge at the target location 380. In such an arrangement, thedirection of propagation of sound waves 370 emitted from the firsttransducer 320, the second transducer 322, and the third transducer 324may be substantially parallel, such that a plurality of approximatelyparallel images may be generated.

As illustrated in FIG. 3, in some examples the first transducer 320, thesecond transducer 322, and the third transducer 324 could includerespective pairs of transducers (i.e., the first transducer 320 includesa first transducer pair, the second transducer 322 includes a secondtransducer pair, and the third transducer 324 includes a thirdtransducer pair). The plurality of transducer pairs 320, 322, 324 couldbe arranged in parallel, such that each respective transducer pair is afixed distance away from an adjacent transducer pair. Paralleltransducers pairs 320, 322, 324 could be spaced at any distance awayfrom an adjacent transducer pair, such as approximately 2 mm to 20 mmapart. The respective transducer pairs 320, 322, 324 could be arrangedsuch that sound waves emitted from the respective pairs 320, 322, 324follow parallel paths, thereby creating an expanded ultrasound imageregion. Such a spacing could allow visualization of a larger field ofview, which may aid in visualization of the needle and/or the targetlocation, particularly if the needle veers could of its specified path.A needle guide 350 may be disposed between two or more of the pluralityof transducers 320, 322, 324 (or transducer pairs) such that a needleinserted through the needle guide 350 is configured to extend toward thetarget location 380. In one example, as illustrated in FIG. 3, theneedle guide could be disposed between a central transducer pair 322,such that the needle following a specified path at approximately thecenter of a viewing plane provided by the transducers 320, 322, 324. Ahousing 310 may further be provided to provide mechanical support forthe arrangement of transducers 320, 322, 324 and/or provide a space forthe coupling of a needle guide 350.

Other transducer configurations are also contemplated. As shown in FIG.4, another aspect of the present disclosure provides a probe 460including a plurality of linear array transducers 420, 422, 424, 426that are arranged in a cross-type configuration. Transducers 420, 422,424, 426 may be positioned in an arrangement such that sound waves 470emitted therefrom create perpendicular viewing planes over a targetlocation 480. In such an embodiment, a needle guide 450 may be disposedbetween the plurality of transducers 420, 422, 424, 426. The needleguide 450 may be positioned in such a way that when a needle is insertedthrough the guide it will pass through the overlapping sound wavesproduced by the plurality of transducers 420, 422, 424, 426 and extendtoward the target location 480. In such an example, the propagationdirection of sound waves 470 from one transducer pairing 420, 424 may beperpendicular to the propagation direction of sound waves from a furthertransducer pairing 422, 426. Such a configuration may allow for moreaccurate visualization of the needle in two dimensions instead of one.

In yet other embodiments, a probe could comprise a plurality oftransducers arranged in a radial fashion, such that sound waves emittedfrom the transducers propagate at multiple angles relative to the targetlocation. In a particular example, a probe could comprise a firsttransducer, a second transducer, and a third transducer arranged about acentral axis. However, other configurations may employ four, five, six,or more transducers arranged about the same central axis. A needle guidemay be configured such that a needle inserted into the needle guideextends along the central axis and toward the target location. Such aconfiguration may allow for better imaging of the needle if it becomesskewed with respect to a linear path (i.e., a path following the centralaxis).

While a number of example embodiments have been provided, it is furtherunderstood that changes, substitutions, adaptations, etc. may be made inthe particular embodiments as described herein while remaining withinthe scope of the present disclosure.

III. Example Methods

FIG. 5 is a flowchart of a method 500 for guiding a needle to a targetlocation using a system (e.g., an interventional ultrasound probesystem) such as any of the systems shown in FIGS. 1A, 1B, 2A, 2B, 3, and4 and described herein. For purposes of illustration, the systemoperated in method 500 includes at least a first transducer, a secondtransducer, and a needle guide. Block 501 of method 500 includespositioning a first transducer and a second transducer proximate to atarget location of a subject, wherein a needle guide is disposed betweenthe first transducer and the second transducer such that a needleinserted through the needle guide is configured to extend toward thetarget location.

The system of the present disclosure may be configured to guide a needleto a range of structures, for instance, a tissue, vessel, tumor, organ,lesion, area of skin, lumen, or body cavity. Thus, in some embodiments,block 501 could include orienting and/or adjusting the transducers sothat the desired target location is within the viewing planes (i.e.,image region) of the transducers of the probe. In some cases, the systemcould be configured for external use, and positioning the firsttransducer and the second transducer could include positioning the firsttransducer and the second transducer over a skin area of the subject. Insuch examples, the transducers may be placed such that a needle insertedthrough the needle guide is configured to extend in a directionsubstantially perpendicular to the skin of the subject.

Additionally or alternatively, in some embodiments the system could beconfigured for internal use (e.g., use within a body cavity, forinstance, the gastrointestinal tract, bronchial tree, rectum, vagina,urethra, ureter, biliary tree, peritoneal cavity, or pleural cavity). Asdescribed elsewhere herein, such embodiments could be incorporated intoan endoscopic probe, an endocavity probe, an endocavitary probe, orother types of internal diagnostic or interventional devices withoutlimitation. In such scenarios, the transducers could be arranged withina probe configured for internal use. Positioning the first transducerand the second transducer could include inserting the probe into a bodycavity of the subject or inserting the probe into a lumen of thesubject. Other target locations and methods of positioning arecontemplated.

In some cases, method 500 could also include adjusting the system suchthat the target location is within the viewing planes of thetransducers. For example, various aspects of the system could beadjusted to guide a needle to a feature deep (e.g., more than 5 mm indepth from a skin surface) within a subject (e.g., an organ or bloodvessel) or, alternatively, to a superficial feature (e.g., a portion ofskin or a subcutaneous structure). Various aspects of the transducerscould be adjusted before or during use in order to optimally guide aneedle while visualizing the needle throughout its path from the needleguide to the target location. In a particular example, the transducerscould be adjusted so as to select a propagation direction of sound wavesemitted by the first transducer and the second transducer such that thesound waves are controllably emitted toward the target location.Additionally or alternatively, adjusting the first and/or secondtransducers could include adjusting the frequency of the sound wavesemitted from the transducers. Such aspects of the transducer operationsmay be adjusted using a controller communicatively coupled to the firstand/or second transducers, or based on interactions with a userinterface of the system.

Block 502 of method 500 includes causing the first transducer and thesecond transducer to emit sound waves, such that at least a portion ofthe sound waves are emitted toward the target location. As described inrelation to FIGS. 1A, 1B, 2A, 2B, 3, and 4, the transducers could beconfigured in a variety of shapes, arrangements, directions, and beamshapes. Causing the first transducer and the second transducer to emitsound waves could include causing the transducers to provide sound wavesthat propagate in the direction of the target location, such that thetarget location is within a viewing plane of the transducers. In someembodiments, sound waves emitted by the transducers include a frequencywithin a frequency range of about 1 MHz to 20 MHz. However, otherfrequencies and frequency ranges are contemplated.

Block 503 of method 500 includes receiving, at the first and secondtransducer, information indicative of reflected sound waves. Theinformation indicative of reflected sound waves could includeinformation relating to a timing of the sound waves, a magnitude of thesound waves, or the spatial location of an incident sound wave. As such,the collected information may be used to determine a location of theneedle of another feature in the viewing plane, a depth or distance ofthe needle or feature, or some other information about the targetlocation.

Block 504 of method 500 includes generating a real-time image of thetarget location based on the received information. In some examples, acontroller of the device is configured to process the information (i.e.,the raw data) received from the first and second transducers prior toconstructing an image of the target location. For instance, dataprocessing could include analog signal conditioning to adjust thetemporal shape of the received information at individual transducerelements; combining the signals from each transducer element into asingle signal representing different spatial locations, and/or adjustingthe temporal shape of the combined ultrasound data. Additional dataprocessing could include filtering and noise reduction steps.

A controller, such as controllers 190, 290, or 390 as illustrated anddescribed in reference to FIGS. 1A, 2A, and 3, may further be configuredto merge the information received from the transducers in real-time tocreate a multilayered and/or 3-dimensional image. In some examples, thecontroller could be an ultrasound image processing unit. Additionally oralternatively, the controller could include software configured torender a real-time 3-dimensional image based on a plurality of images ofthe needle and/or target location. In reference to FIG. 6A, method 500could include producing multiple images (e.g, ultrasound images)corresponding to respective views of the target location from each ofthe plurality of transducers. In such an example, a first image 602 ofthe target location is produced based on the reflected sound wavesreceived at the first transducer, and a second image 604 of the targetlocation is produced based on the reflected sound waves received fromthe second transducer. As shown in FIG. 6B, a real-time image 606 of thetarget location may then be formed by overlaying the two or more images602, 604 generated by the first and second transducers. In such ascenario, generating a real-time image 606 of the target location basedon the received information could include generating a first image 602of the target location based on information received by the firsttransducer; generating a second image 604 of the target location basedon information received by the second transducer; and overlaying thefirst image 602 and the second image 604 to provide the real-time image606.

As illustrated in FIGS. 6A-B, a plurality of images 602, 604 from aplurality of respective transducers may be merged to generate areal-time image of the target location. In some examples, the real-timeimage could be a 3-dimensional image generated (i.e., rendered) based onimages from a first transducer, a second transducer, and/or furthertransducers. The 3-dimensional real-time image may be generated bydetermining a spatial location of the plurality of transducers, andusing their relative spatial arrangement to render a 3-dimensionalimage. In one example, overlaying the first image 602 and the secondimage 604 could include determining a relative angle between a plane ofthe first transducer and a plane of the second transducer. A real-time3-dimensional rendering could be generated based on at least therelative angle between the planes of the first and second transducers.Additional information relating to the transducers could also be used togenerate a 3-dimensional real-time image. For instance, in some examplesthe information could include a distance between the first transducerand the second transducer, a distance and/or angle between the firstand/or second transducer and the target location, or some otherinformation.

Images from the two or more transducers could be overlaid based onidentifying a structure (e.g., a structure representing the location ofthe needle or another feature in the target location) that is visible inboth the first image 602 and the second image 604. For example, in theultrasound images shown in FIGS. 6A-B, the location of the tip of theneedle 610 a, 610 b is indicated with a white dot. A plurality of imagesdisplaying the same feature (e.g., a tip of a needle 610 a, 610 b) maybe superimposed by identifying the location of the needle or othershared features in each image 602, 604, and overlaying the images sothat the shared features converge (e.g., by overlapping the location ofthe needle in the first image 610 a with the location of the needle inthe second image 610 b). In such a scenario, overlaying the first image602 and the second image 604 could include determining a first structure610 a corresponding to the needle in the first image 602 and determininga second structure 610 b corresponding to the needle in the second image604. Overlaying the images 602, 604 could then include overlaying thefirst image 602 and the second image 604 based on a superimposition ofthe first structure 610 a and the second structure 610 b. Additionallyor alternatively, other features of the target location could be used tooverlay the images 602, 604. In various examples, these features couldinclude vessels, organs, lumens, tissue interfaces, tumors, lesions, orother biological structures visible in the two or more ultrasoundimages.

As described in relation to FIGS. 3 and 4, in certain examples the probecould include a third or further transducer, and a real-time image couldbe generated with information received from the plurality oftransducers. The method 500 may then include positioning a thirdtransducer proximate to the target location; causing the thirdtransducer to emit sound waves, such that at least a portion of thesound waves emitted from the third transducer are emitted toward thetarget location; and receiving, at the third transducer, informationindicative of reflected sound waves. After receiving informationindicative of reflected sound waves at the third transducer, thisadditional information may then be used for rendering a real-time image,i.e., information from the third transducer may be used to generate athird image of the target location, and the third image may be overlaidon the first and/or second images to generate a real-time image.

Furthermore, block 505 of method 500 includes inserting a needle throughthe needle guide so as to intersect with the target location. The pathof the needle through the guide and into the subject may pass throughoverlapping viewing planes provided by the first and second transducer,such that the needle is visualized in the real-time image. In otherwords, in some embodiments herein the needle guide constrains the needlein a specified path, the path extending toward the target location.Inserting the needle through the needle guide could include extendingthe needle along the specified path. In some examples, the specifiedpath extends perpendicular to the subject's skin, and inserting theneedle through the needle guide could comprise inserting the needlesubstantially perpendicular to a skin surface of the subject. However,in other examples, the specified path could be oriented at any anglerelative to skin of a subject, relative to the probe, or on anotherspecified path. In yet further examples, the needle and/or needle guidemay be manipulable, such that a user of the method can control the pathof the needle. A user of method 500 may then be able to manipulate theneedle as necessary to reach the target location or a feature within thetarget location.

The example method 500 illustrated in FIG. 5 is meant as anillustrative, non-limiting example. Blocks and steps described hereinmay be carried out sequentially or in parallel. Furthermore, the variousblock and steps could be carried out in a different order than describedherein and some blocks and steps could be omitted, skipped, and/orrepeated. Additional or alternative elements of the method andadditional or alternative components of the system are contemplated.

What is claimed is:
 1. A system comprising: a probe comprising: a firsttransducer; and a second transducer, wherein the first transducer andthe second transducer are arranged such that sound waves provided by thefirst and second transducers are emitted toward a target location of asubject; and a needle guide detachably coupled to the probe, wherein theneedle guide is disposed between the first transducer and the secondtransducer such that a needle inserted through the needle guide isconfigured to extend toward the target location.
 2. The system of claim1, wherein at least one of the first transducer or the second transducercomprise a linear array transducer.
 3. The system of claim 1, whereinsound waves provided by the first transducer propagate along a firstpropagation direction, wherein sound waves provided by the secondtransducer propagate along a second propagation direction.
 4. The systemof claim 3, wherein the first propagation direction and the secondpropagation direction are perpendicular.
 5. The system of claim 3,wherein the first propagation direction and the second propagationdirection can be selected, such that sound waves provided by the firsttransducer and the second transducer are controllably emitted toward aselectable target location.
 6. The system of claim 1, wherein the probefurther comprises a third transducer, wherein the third transducer isarranged such that sound waves provided by the third transducer areemitted toward the target location.
 7. The system of claim 6, whereinthe first transducer comprises a first transducer pair, wherein thesecond transducer comprises a second transducer pair, wherein the thirdtransducer comprises a third transducer pair, and wherein the firsttransducer pair, the second transducer pair, and the third transducerpair are arranged in parallel such that each respective transducer pairis a fixed distance away from an adjacent transducer pair.
 8. The systemof claim 6, wherein the first transducer, the second transducer, and thethird transducer are coupled according to an arrangement, wherein thearrangement comprises a concave shape.
 9. The system of claim 6, whereinthe first transducer, the second transducer, and the third transducerare arranged about a central axis, and wherein the needle guide isconfigured such that a needle inserted into the needle guide extendsalong the central axis toward the target location.
 10. The system ofclaim 1, further comprising a controller communicatively coupled to thefirst transducer and the second transducer.
 11. The system of claim 10,wherein the controller communicates with the first and secondtransducers via a wireless communication protocol.
 12. The system ofclaim 10, wherein the controller is configured to adjust a frequency ofsound waves emitted by at least one of: the first transducer or thesecond transducer.
 13. The system of claim 1, wherein the needle guidecomprises a coupler configured to secure the needle guide to the probe,wherein the coupler comprises at least one of: a shaft coupling, amagnetic coupling, a clip coupling, or a mating coupling.
 14. The systemof claim 1, wherein the sound waves comprise one or more frequencieswithin a frequency range of about 1 MHz to 22 MHz.
 15. A methodcomprising: positioning a first transducer and a second transducerproximate to a target location of a subject, wherein a needle guide isdisposed between the first transducer and the second transducer suchthat a needle inserted through the needle guide is configured to extendtoward the target location; causing the first transducer and the secondtransducer to emit sound waves such that at least a portion of the soundwaves are emitted toward the target location; receiving, at the firstand second transducers, information indicative of reflected sound waves;generating a real-time image of the target location based on thereceived information; and inserting a needle through the needle guide soas to intersect with the target location.
 16. The method of claim 15,wherein the needle guide is configured to constrain the needle along aspecified path toward the target location, and wherein inserting theneedle through the needle guide comprises extending the needle along thespecified path.
 17. The method of claim 16, wherein the specified pathis substantially perpendicular to a skin surface of the subject.
 18. Themethod of claim 15, wherein the first transducer and the secondtransducer are arranged in a probe, wherein positioning the firsttransducer and the second transducer comprises at least one of:insertion of the probe into a body cavity of the subject or insertion ofthe probe into a lumen of the subject.
 19. The method of claim 15,wherein generating a real-time image of the target location based on thereceived information comprises: generating a first image of the targetlocation based on information received by the first transducer;generating a second image of the target location based on informationreceived by the second transducer; and overlaying the first image andthe second image to provide the real-time image.
 20. The method of claim19, wherein overlaying the first image and the second image comprises:determining a relative angle between a plane of the first transducer anda plane of the second transducer; and overlaying the first image and thesecond image based on at least the determined relative angle.